Search results for " DoE"
Article
From Darwin to Recombinant Fc Multimers
Though considered as a good and established approach, Sejergarrd pointed out several of the inherent drawback of the DoE approach and Latin Hypercube Sampling (LHS) was introduced as a possible altern…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
While they are preferred over empirical models, the complexity of most chromatography operations does not lend itself to mechanistic modeling and hybridization of the mechanistic model. Traditional ap…
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Platform Approach Speeds Process Development
Next, a variable number of cultivation parameter screening and optimization studies are performed in controlled bench-scale bioreactors including DoE approaches. Process fixation and process consolida…
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Going Small to Achieve Success on the Commercial Scale
Because they are models, however, such a situation does not occur. The goal, therefore, is to mimic the commercial-scale process as closely as possible.
The impact of QbD and DoE
The quality-b…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
By using DoE, it is possible to reduce the number of cultures necessary to characterize the process design space. By reducing the ability of the model to detect higher-order interactions—so that main …
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Improving PAT for Biologics
“The cost for DoEs in the biopharmaceutical industry can be quite high, and DoEs can also be quite time consuming, making the use of PAT difficult. One solution may be to work with small volumes and r…
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Biopharma Outsourcing Activities Update
Industry plans more outsourcing
Whatever the reason(s) for the apparent reining in of specific outsourcing in 2014, there doesn’t seem to have been a concurrent pull back in planned levels of futur…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
It doesn’t help that the guidance documents for industry have been vague on where this criticality threshold lies. The FDA’s PV guidance avoids the issue: “attribute(s) … and parameter(s) … are not ca…
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A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…